Healthy Japanese adults
Conditions
Interventions
Duration: 8 weeks Test material: Active capsule Dose: Take 3 capsules per day Administration: Take a capsule after breakfast, lunch, and dinner. * If you cannot eat either breakfast or lunch, take
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. Subjects experiencing stress in daily 3. Subjects whose the result of the Helicobacter pylori antibody test is negative at screening and examination before ingestion and are judged as eligible to participate in the study by the principal investigator 4. Among the subjects who met 3rd inclusion criteria, subjects whose LF/HF ratio at autonomic function test is relatively high
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are pregnant, breast-feeding, and plan to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 8. Subjects who are judged as ineligible to participate in the study by the principal investigator 9. Subjects who have been diagnosed with Helicobacter pylori infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Autonomic function * Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform the test before and after psychological stress load. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Salivary amylase activity 2. Salivary cortisol activity 3. Pepsinogen I (PGI) 4. Pepsinogen II (PGII) 5. PGI/PGII 6. Profile of Mood States 2nd Edition (POMS2) Japanese version 7. Izumo Scale 8. Original questionnaires 8a. Visual Analogue Scale (VAS) 8b. Likert scale *1-6,8a Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform these assessments before and after psychological stress load. *7,8b Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform the assessment before psychological stress load. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed